Internet-delivered Emotion Regulation Individual Therapy or Adolescents (IERITA) With Self-injury Within Child and Adolescent Mental Health Services

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age13-17
SponsorKarolinska Institutet

About this trial

The overall purpose of the study is to implement and evaluate IERITA (Internet-delivered Emotion Regulation Individual Therapy for Adolescents) within child and adolescent mental health services for adolescents engaging in nonsuicidal self-injury (NSSI) and optimize treatment outcomes for those adolescents at risk of non-remission (continued NSSI).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

13-17 years old

At least one self-injury episode in the past three months

A parent willing to engage in the parent program

Disqualifiers

Immediate suicide risk

Global functioning corresponding to a rating ≤40 of the Children's Global Assessment Scale (CGAS)

Social problems needing immediate intervention (e.g., violence within the family)

Ongoing dialectical behavior therapy for adolescents

Trial design

Design model

Parallel

Treatments tested in this trial

  • Adaptable IERITA

    Behavioral

    IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support. In the adapted IERITA intervention, the therapists develop an individual case conceptualization that forms the basis for a brief interview with the adolescent after the classification phase (from randomization to treatment week four), during which potential obstacles and necessary adaptations are explored. Adaption can entail scheduled or regular chats or videoconferences, selecting specific material to focus on, and involving additional support persons. The adapted IERITA intervention is offered after the classification phase until treatment week 12.

  • Standard IERITA

    Behavioral

    IERITA is a 12-week acceptance-based behavioral therapy. The goal is to reduce self-injury through learning and using other ways to regulate emotions. IERITA includes modules where the participants can read text, watch videos, listen to audio, and message their allocated therapists. The adolescent treatment is 11 modules, and the parent course is six. Both adolescents and parents receive separate asynchronous online therapist support.

  • Treatment as usual

    Other intervention

    Participants are free to any receive regular care (i.e., psychosocial treatment, medications, or a combination of both) as needed during the trial.

Treatment groups

341 Participants
are divided into 2 treatment groups
Group A: Adaptable Internet-delivered emotion regulation individual therapy adjunctive to treatment as usualExperimental treatment 2 interventions
Group B: Standard Internet-delivered emotion regulation individual therapy adjunctive to treatment as usualActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Deliberate Self-harm Inventory - Youth version (DSHI-Y)

The DSHI-Y measures the frequency of the most common NSSI behaviors. The primary outcome will be the proportion of treatment remission. Remission will be defined as the absence of self-injury the past 30 days. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.

Time frame
One-, three- and twelve-months post-treatment

Secondary outcomes

1

Deliberate Self-harm Inventory - Youth version (DSHI-Y)

The DSHI-Y measures the frequency of the most common NSSI behaviors. Change in NSSI frequency from baseline to respective follow-up will be a secondary outcome. The primary outcome measure will be the clinician-rated DSHI-Y. In cases where clinician ratings are unavailable, the self-rated DSHI-Y will be used.

Time frame
Baseline, one-, three- and twelve-months post-treatment
2

Children's Global Assessment Scale (CGAS)

The CGAS measures global functioning on a single item ranging from 1 to 100, with a higher value indicating better functioning. Clinician-rated.

Time frame
Baseline, one-, three- and twelve-months post-treatment
3

Difficulties in Emotion Regulation Scale - 16 item version (DERS-16)

The DERS-16 measures difficulties in emotion regulation. The total score ranges from 16 to 80, with higher scores indicating greater difficulties. Self-rated (adolescent and parent).

Time frame
Baseline, one-, three- and twelve-months post-treatment
4

Child Health Utility 9D (CHU-9D)

The CHU-9D measures health related quality of life. The scale has 9 items with a summary score between 9 and 45, where a higher score indicates greater health-related quality of life. Self-rated (adolescent).

Time frame
Baseline, one-, three- and twelve-months post-treatment

Other outcomes

1

Internet Intervention Patient Adherence Scale (iiPAS)

The IIPAS measures patient adherence to guided internet-delivered behavioral interventions. This scale has 5 items, and a total score ranging from 0 to 20, where 0 indicates no adherence and 20 perfect adherence. Clinician-rated.

Time frame
Treatment week 3 and post-treatment (week 12)
2

Participant-rated adherence

Two items asking the participant to rate their own adherence the past week. Self-rated (adolescent).

Time frame
Treatment week 3
3

Credibility

Two items asking the participant to rate change in treatment credibility from the previous treatment week. Self-rated (adolescent).

Time frame
Treatment week 3
4

Credibility/Expectancy Questionnaire (CEQ) - 1 item version

CEQ measures treatment credibility and expectancy. This version of the scale has 1 item ranging from 0 to 100, with higher scores indicating greater credibility/expectancy. Self-rated (adolescent).

Time frame
Treatment week 2

Sponsors and contacts

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Karolinska Institutet

Lead sponsor

Region Stockholm

Collaborator

Region Skane

Collaborator

Vastra Gotaland Region

Collaborator